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Jevtana (cabazitaxel) - Potential for Medication Errors During Preparation Leading to Overdose - For Health Professionals

Health Canada Endorsed Important Safety Information on the potential for medication error in the preparation of JEVTANA® (cabazitaxel for injection)

January 10, 2014

Dear Healthcare Professional,

Subject: Potential for medication error in the preparation of JEVTANA® (cabazitaxel)

Sanofi-aventis Canada Inc., in consultation with Health Canada, would like to bring to your attention the potential for medication errors leading to overdose in the preparation of JEVTANA® (cabazitaxel), and the importance of ensuring that the entire content of the diluent is added to the concentrate vial during reconstitution.

JEVTANA® (cabazitaxel) in combination with prednisone or prednisolone is indicated for the treatment of patients with castration resistant (hormone refractory) metastatic prostate cancer previously treated with a docetaxel containing regimen.

Reconstitution errors with JEVTANA (cabazitaxel) have been reported in Europe that led to overdoses 15% to 20% higher than the prescribed dose. No cases of reconstitution errors have been reported in Canada.

Errors in the administered dose occurred in the first step of the reconstitution where only the nominal volume of the diluent vial (4.5 mL) was transferred to the concentrate vial, instead of the entire content (5.67 mL). This resulted in a more concentrated premix, leading to a higher dose of JEVTANA delivered.

Pharmacies should review worksheets used in the preparation of cabazitaxel to ensure that they instruct pharmacy staff to add the ENTIRE content of the diluent vial to the concentrate.

Where an automated software system is used to prepare the infusion solution, the system must be set up to allow withdrawal of the ENTIRE content of the diluent vial to add to the concentrate vial.

The anticipated complications of overdose include exacerbation of adverse reactions such as bone marrow suppression and gastrointestinal disorders (see section Overdose of the JEVTANA® Product Monograph).

Preparation instructions

Preparation of the infusion solution of JEVTANA requires two dilution steps. Both the cabazitaxel concentrate vial and the diluent vial contain an overfill to compensate for liquid loss during preparation.

Step 1: Initial dilution of the concentrate: Always transfer the ENTIRE content of the diluent vial to the concentrate in order to obtain a concentration of 10 mg/mL in the premix.

Table 1

Diluent vial

Concentrate vial

Nominal volume

4.5 mL

1.5 mL (60 mg cabazitaxel)

Actual fill volume

5.67 mL (add all of this volume to the concentrate vial)

1.83 mL (73.2 mg cabazitaxel)

Step 2: Preparation of the infusion solution: From this premix, the required volume should be taken and injected into the infusion container in accordance with the intended dose of JEVTANA to be administered to the patient.

Health Canada is working with sanofi-aventis Canada Inc. to improve the clarity of the dilution instructions in the Product Monograph for JEVTANA® and this will be posted on the Health Canada and sanofi-aventis Canada Inc. Web sites.

Should you have any questions or require additional information regarding the use of JEVTANA®, please contact the Medical Information Department at sanofi-aventis Canada at 1-800-265-7927, Monday to Friday, between 7:30 a.m. and 7:30 p.m. (Eastern Standard Time).

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of reconstitution errors or other serious or unexpected adverse reactions in patients receiving JEVTANA® should be reported to sanofi-aventis Canada Inc. or Health Canada. Medication errors can also be reported to the Institute for Safe Medication Practices (ISMP) Canada through the Canadian Medication Incident Reporting and Prevention System.